The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Holland Netherlands. Our client based in Amsterdam, opened a new position for a highly motivated individual to be part of a team that works on innovative T cell therapy for cancer treatment.
Role descriptionYou will be responsible for media preparation, material staging, waste handling, sample delivery, visual inspection/cryo-preservation of drug product in a cGMP manufacturing facility. In this role, you will ensure that all components are adequately supplied to follow the production schedule, and due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process.
ResponsibilitiesYour responsibilities, among others, will be:
· To perform tasks associated with the manufacturing of clinical and commercial products following batch records and standard operating procedures (SOPs) in B, D and CNC grade
· To work as part of a dedicated and committed team to execute GMP runs in close collaboration with Product Sciences, Material Management, and Quality Assurance & Quality
· To assist in optimization of SOPs and Batch records, revise existing Manufacturing Batch Records, SOPs, WIs to support process improvements and maintain GMP compliance;
· Assist in investigations required to manage deviations;
· Assist in managing change controls;
· To strictly comply with SOPs and cGMP regulations; accurately complete documentation associated with clinical and commercial manufacturing;
· To ensure a consistent process execution to guarantee high quality output;
· To maintain cleanroom in an optimal state;
· To continuously look for improvements to the processes to increase quality and efficiency.
Challenges of the role:
· Contribute to the growth of the company
· Ability to work in a brand new state-of-the-art manufacturing plant
The ideal candidates for this position, in combination with skills and knowledge, should also have a ‘hands-on, can-do’ mentality. You must also be comfortable with working in full gowning requirements in a completely aseptic environment.
· MBO Level with a minimum of two (2) years of cGMP experience in a pharmaceutical / biotechnology manufacturing environment;
· Must have demonstrated knowledge of pharmaceutical manufacturing of biotechnology products;
· Skilled in Microsoft word, Excel and data analysis;
· Be passionate about following SOPs, curious and interested in learning and growing;
· Be comfortable in a fast-paced, growing company environment with minimal direction and able to adjust workload based upon changing priorities;
· Be self-motivated and willing to accept temporary responsibilities outside of initial job description;
· Have excellent interpersonal, verbal and written English communication skills (essential in our collaborative work environment);
· Have good judgment, problem solving and analytical skills.
· Work in shifts and have the willingness to accommodate schedule adjustments.
Other informationAs they extend their global reach, we need colleagues interested in change, in challenge, and in building a new future together. If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Rutger Koning